The primary objective of this study is to evaluate the efficacy and tolerance of a moisturizer SPF 50+ when used over a 12-week time period by women with moderate to severe facial photodamage.
This was a single center, single-cell, 12-week clinical trial on female subjects (Fitzpatrick Skin Type I-VI, evenly distributed) between 35-60 years of age with moderate to severe overall facial photodamage. All subjects were provided Revision Skincare Gentle Foaming Cleanser and Facial Moisturizer (Goodier Cosmetics) at the Screening visit after eligibility was confirmed. These products were used twice daily as instructed for a minimum 3 days prior to the Baseline visit (washout phase). At Baseline, subjects were given Sunscreen Moisturizer SPF 50+ to replace their Facial Moisturizer morning application. Subjects continued to use the Facial Moisturizer given at Screening in the evening. Clinical grading assessments, full face images, Corneometer, Ultrasound, and subject self-assessment questionnaires were completed at each study visit (Baseline, Week 4, 8, and 12). Full face images were also completed post-application at Baseline. A total of 34 subjects completed the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
A provided anti-aging sunscreen moisturizer SPF 50 was used once a day.
A provided Gentle Cleansing Lotion (Revision Skincare) was used 2x daily (AM/PM).
A provided facial moisturizer (Goodier) was used 1x daily (PM).
Skin Study Center, KGL LLC
Newtown Square, Pennsylvania, United States
Improvement in Clinical Efficacy Parameters at weeks 4, 8, and 12 versus Baseline
The primary efficacy endpoint will be Investigator Clinical Grading using a Modified Griffiths' 10-point scale. The scale ranges from 0 = none (best possible condition) to 9 = severe (worst possible condition). A decrease in score at post-baseline timepoints compared to baseline indicates an improvement. The parameters are fine lines (global face), wrinkles (global face), global hyperpigmentation (mottled and discrete), skin roughness (tactile), skin tone evenness (uniformity of skin color), overall photodamage, radiance (perceived glow), and skin firmness (tactile).
Time frame: 12 weeks
Lack of significant increase in Objective Tolerability Parameters at weeks 4, 8, and 12 compared to Baseline
The primary tolerability endpoint will be the Investigator Tolerability Assessment of erythema, edema, and scaling/peeling of the face and neck. The 4-point scale ranges from 0 = none to 3 = severe. A decrease in score at post-baseline timepoints compared to baseline indicates an improvement.
Time frame: 12 weeks
Lack of significant increase in Subjective Tolerability Parameters at weeks 4, 8, and 12 compared to Baseline
The secondary tolerability endpoint will be the Subjective Tolerability Assessment of burning/stinging, itching, and tightness/dryness of the face and neck. The 4-point scale ranges from 0 = none to 3 = severe. A decrease in score at post-baseline timepoints compared to baseline indicates an improvement.
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.